Pharmaceutical Formulation Characterization Design, 2nd Edition

A special issue of Pharmaceuticals (ISSN 1424-8247). This special issue belongs to the section "Pharmaceutical Technology".

Deadline for manuscript submissions: 15 September 2026 | Viewed by 3099

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Guest Editor
Institute of Pharmaceutical Technology and Regulatoy Affairs, University of Szeged, Eötvös u. 6., H-6720 Szeged, Hungary
Interests: buccal polymer films; mucoadhesion; proteins; Quality by Design; permeation enhancing
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Guest Editor
Institute of Pharmaceutical Technology and Regulatoy Affairs, University of Szeged, Eötvös u. 6., H-6720 Szeged, Hungary
Interests: solid dosage forms; tablets; Quality by Design; factorial design; artificial neural network
Special Issues, Collections and Topics in MDPI journals

Special Issue Information

Dear Colleagues,

This Special Issue of Pharmaceuticals is dedicated to reporting the latest scientific results in the field of "Formulation Characterization Design". At present, it is very important that, before the industrial production of pharmaceuticals, a given pharmaceutical form is extensively tested, which includes various structural tests, physical tests, and pharmacokinetic tests. It is necessary to find out whether there is any change in the active ingredient during pharmaceutical technological processes and whether this could influence the development of the effect. It is necessary to understand the relationships between different structural properties, the dissolution profile, and the effect on development in order to be able to design medicines more efficiently based on new knowledge. Appropriate planning is also very important and can be achieved primarily through risk analysis, the Quality by Design (QbD) approach, and the use of factorial experimental design (DoE). It is possible to determine the design space, which provides accurate information about the Critical Process Parameter (CPP) values, within which the product with the quality target product profile (QTPP) will be suitable. Based on these, we can gain new knowledge and connections that are essential for efficient production later on. This Special Issue primarily publishes results related to the above-mentioned topics or those that are similar, mainly in the field of solid dosage formulation or intermediate products that can be used in them. We welcome papers from both the field of traditional dosage forms such as tablets, granules, and innovative dosage forms such as buccal films, inhalation powders, nasal preparations, transdermal drug delivery systems, etc.

Dr. Katalin Kristó
Dr. Tamás Sovány
Guest Editors

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Keywords

  • Quality by Design
  • factorial design
  • design space
  • solid dosage forms
  • risk assessment
  • critical process parameters
  • quality target product profile

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Published Papers (3 papers)

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Research

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19 pages, 2511 KB  
Article
Investigation of Cytotoxicity, Permeability, and Stability of Captopril-Loaded Chitosan-Ascorbate Buccal Films
by Hala Rayya, Raghad Alsheikh, Dániel Nemes, Lajos Nagy, Géza Regdon, Jr., Ildikó Bácskay, Katalin Kristó and Krisztián Pamlényi
Pharmaceuticals 2026, 19(7), 1058; https://doi.org/10.3390/ph19071058 - 8 Jul 2026
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Abstract
Background: Buccal films have attracted continued interest due to their several advantages. However, developing effective buccal films for hydrophilic drugs remains challenging due to limited buccal permeability. Captopril, a water-soluble ACEI, represents a suitable model for evaluating buccal films. Chitosan–ascorbate has previously [...] Read more.
Background: Buccal films have attracted continued interest due to their several advantages. However, developing effective buccal films for hydrophilic drugs remains challenging due to limited buccal permeability. Captopril, a water-soluble ACEI, represents a suitable model for evaluating buccal films. Chitosan–ascorbate has previously been studied in solution for its cytotoxicity and permeation-enhancing properties. However, its performance as a buccal-film dosage form requires further investigation. The present study extends earlier formulation work by evaluating the in vitro cytotoxicity, permeability, and stability of captopril-loaded chitosan–ascorbate buccal films. Methods: Blank and captopril-loaded films were assessed. Cytotoxicity and permeability were evaluated using TR146 cells and compared with chitosan–acetate films as a reference. Accelerated stability test (40 °C/75% RH, three months) was performed to monitor moisture content, mechanical properties, and drug content. FT-IR spectroscopy was used to investigate potential chemical interactions. Results: All films maintained cell viability above 80%. Chitosan–ascorbate films significantly increased captopril permeation compared with chitosan–acetate films, achieving up to a 12–16-fold increase in cumulative drug permeation. The stability test did not reveal any new chemical reactions or interactions based on FT-IR analysis, indicating that the polymer system remained structurally stable; however, it showed continuous moisture uptake, slight deterioration of mechanical properties and a decrease in drug content. Conclusions: This study provides an in vitro, dosage-form–level evaluation of captopril-loaded chitosan–ascorbate buccal films, demonstrating acceptable cytocompatibility and moderate enhancement of permeability. However, significant moisture sensitivity under accelerated conditions can represent limitations, highlighting the importance of protective packaging or further formulation optimization to overcome this. Full article
(This article belongs to the Special Issue Pharmaceutical Formulation Characterization Design, 2nd Edition)
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21 pages, 2296 KB  
Article
Formulation, Physicochemical Optimization, and Forensic Evaluation of Zinc Oxide- and Curcumin-Loaded Solid Lipid Nanoparticles for Safe Fingerprint Detection in Forensic Medicine
by Ahmed A. Katamesh, Rehab Abdelmonem, Sarah A. Khater, Hadel A. Abo El-Enin, Abdullah A. Alshehri, Noran Khaled, Khadiga A. Fattah and Inas Essam Ibrahim Al-Samadi
Pharmaceuticals 2026, 19(6), 904; https://doi.org/10.3390/ph19060904 - 6 Jun 2026
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Abstract
Purpose: Nano-forensics is the latest application of nano-based technology for the purpose of fingerprint detection to improve precision, expedite investigations, and enhance safety. Solid lipid nanoparticles (SLNs) represent a promising pharmaceutical nanocarrier system for different applications. This study focused on applying ZnO [...] Read more.
Purpose: Nano-forensics is the latest application of nano-based technology for the purpose of fingerprint detection to improve precision, expedite investigations, and enhance safety. Solid lipid nanoparticles (SLNs) represent a promising pharmaceutical nanocarrier system for different applications. This study focused on applying ZnO and/or curcumin nanoparticles (NPs) to SLNs for the purpose of fingerprint detection to improve their sensitivity, safety and selectivity. Methods: A factorial design was utilized to select the optimized Cur-SLNs and ZnO-SLNs on the basis of the smallest particle size (PS), the lowest polydispersity index (PDI) and the highest zeta potential (ZP) value. To select the safe SLN-NPs, a cytotoxicity test was applied and they were compared to the most commonly applied product in fingerprint detection. The optimized formula was investigated according to the morphological structure; confocal spectroscopy and a stability study at different storage conditions were applied. Then the SLN-NPs were evaluated for their sensitivity, efficacy and selectivity in fingerprint detection. Results: The obtained optimal Cur-SLNs and ZnO-SLNs showed a nano PS of 221.55 ± 1.34 nm and 313.950 ± 1.87 nm, respectively, a PDI value < 0.7 and a ZP > 20 mV. The cytotoxicity data demonstrate that Cur-SLNs have low toxicity, so they will be the chosen formula. TEM and Raman spectroscopy analysis of the optimized Cur-SLN formulation validated the encapsulation efficiency and structural integrity of the pharmaceutical nanosystem. Furthermore, the powder showed stability and good results with higher adherence but smudged the prints on surfaces due to the slightest moisture. Conclusions: Overall, the results confirmed that Cur-SLN nanopowders can be developed as a suggested alternative to the current toxic powders used for latent fingerprint detection in forensic science, but only after further research on various surfaces and in different conditions. Full article
(This article belongs to the Special Issue Pharmaceutical Formulation Characterization Design, 2nd Edition)
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Review

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25 pages, 6594 KB  
Review
Ambient-Stable mRNA Medicines: Emerging Paradigms in Dry and Solid-State Formulation
by Mohamed El-Tanani, Syed Arman Rabbani, Adil Farooq Wali, Frezah Muhana, Alaa A. A. Aljabali, Yahia El-Tanani and Rakesh Kumar
Pharmaceuticals 2026, 19(3), 370; https://doi.org/10.3390/ph19030370 - 26 Feb 2026
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Abstract
The medical field now uses mRNA therapeutics to deliver fast programmable treatment options through versatile vaccination platforms. The worldwide adoption of mRNA therapeutics faces a major obstacle because these molecules require extreme cold storage and transportation systems. mRNA stability establishes a fundamental scientific [...] Read more.
The medical field now uses mRNA therapeutics to deliver fast programmable treatment options through versatile vaccination platforms. The worldwide adoption of mRNA therapeutics faces a major obstacle because these molecules require extreme cold storage and transportation systems. mRNA stability establishes a fundamental scientific and industrial challenge which requires researchers to unite formulation design with process control and material engineering for cold-chain independence. Current knowledge about RNA hydrolysis and lipid oxidation and water-mediated degradation is combined with new methods for solid-state stabilization through lyophilization and spray-freeze-drying and thin-film technologies. Mechanism such as vitrification, water replacement and excipient RNA interactions are assessed to establish the fundamental chemical properties needed for extended product stability. Advanced mRNA development strategies are also examined, including self-amplifying and circular RNA structures and nano-glass and metal–organic frameworks and artificial intelligence-based predictive design for creating stable mRNA formulations at room temperature. This review examines manufacturing and regulatory and logistical obstacles which affect real-world implementation of mRNA therapeutics through assessments of production scale and product quality tests and packaging strength and tropical environment testing. The combination of research findings presents a path to develop mRNA medicines which maintains their effectiveness when stored at 25 °C or above, thus enabling worldwide access to RNA-based treatments. The development of mRNA into a durable therapeutic platform requires scientists to merge molecular research with process development and regulatory standardization. Full article
(This article belongs to the Special Issue Pharmaceutical Formulation Characterization Design, 2nd Edition)
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